Fused Deposition Modeling as a Possible Approach for the Preparation of Orodispersible Tablets

Additive manufacturing technologies are considered as a potential way to support individualized pharmacotherapy due to the possibility of the production of small batches of customized tablets characterized by complex structures. We designed five different shapes and analyzed the effect of the surface/mass ratio, the influence of excipients, and storage conditions on the disintegration time of tablets printed using the fused deposition modeling method. As model pharmaceutical active ingredients (APIs), we used paracetamol and domperidone, characterized by different thermal properties, classified into the various Biopharmaceutical Classification System groups. We found that the high surface/mass ratio of the designed tablet shapes together with the addition of mannitol and controlled humidity storage conditions turned out to be crucial for fast tablet’s disintegration. As a result, mean disintegration time was reduced from 5 min 46 s to 2 min 22 s, and from 11 min 43 s to 2 min 25 s for paracetamol- and domperidone-loaded tablets, respectively, fulfilling the European Pharmacopeia requirement for orodispersible tablets (ODTs). The tablet’s immediate release characteristics were confirmed during the dissolution study: over 80% of APIs were released from printlets within 15 min. Thus, this study proved the possibility of using fused deposition modeling for the preparation of ODTs.

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About this article: Tranová, T.; Pyteraf, J.; Kurek, M.; Jamróz, W.; Brniak, W.; Spálovská, D.; Loskot, J.; Jurkiewicz, K.; Grelska, J.; Kramarczyk, D.; Mužíková, J.; Paluch, M.; Jachowicz, R. Fused Deposition Modeling as a Possible Approach for the Preparation of Orodispersible Tablets. Pharmaceuticals 2022, 15, 69. https://doi.org/10.3390/ph15010069

Materials
Paracetamol (N-(4-hydroxyphenyl)acetamide) granules (96% API content) manufactured by fluid bed granulation with polyvinylpyrrolidone, supplied by Anqiu Lu’an Pharmaceutical Co., Ltd. (Anqiu, China) and Domperidone (6-chloro-3-[1-[3-(2-oxo-3H-benzimidazol-1-yl)propyl]piperidin-4-yl]-1H-benzimidazol-2-one) (Sri Krishna Pharmaceuticals, Ltd., Hyderabad, Telangana, India) served as model active ingredients. Poly(vinyl alcohol) (PVA, Parteck® MXP, Merck® KGaA, Darmstadt, Germany) was used as the matrix-forming polymer to prepare filaments and 3D printed tablets. Crospovidone (Kollidon® CL, BASF®, Ludwigshafen, Germany) was utilized as a disintegrant, while Mannitol (Avantor® Performance Materials Poland S.A., Gliwice, Poland) was added to plasticize the formulations. Hydrochloric acid solution (Merck® KGaA, Darmstadt, Germany) was used to prepare the medium for drug-loading and dissolution tests of domperidone-loaded tablets. The water used in all tests was produced by Elix 15UV Essential reversed osmosis system (Merck® KGaA, Darmstadt, Germany).